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First-Episode PsychosisEarly Phase 1NCT05967195

Trial to Increase FEP Attendance

A Early Phase 1 study testing Financial Incentive and Text-Messages in people with First-Episode Psychosis, run by University of Pennsylvania at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
First-Episode Psychosis
What is being tested?
Financial Incentive and Text-Messages
How many people
145 participants
Where
3 sitesUnited States
Study dates
1 Feb 2025to 31 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For all participants, age ≥ 18 years old.
  • For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
  • For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
  • For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form

Who cannot join

  • For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
  • For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
  • For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • PEACE Program, Horizon House, Inc.

    Philadelphia, Pennsylvania, 19123

  • University of Pennsylvania

    Philadephia, Pennsylvania, 19104

  • University of North Carolina at Chapel Hill (ENCOMPASS Program)

    Raleigh, North Carolina, 27608

Other trials in United States

About this study

Official title: Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study

Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. The trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.

Being tested
Financial Incentive and Text-Messages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial Incentive and Text-MessagesBehavioural

    Patient-participants will receive modest financial incentive for attending therapy or medication management appointments combined with text messages to encourage attendance at these appointments. Text messages will be informed by principles of behavioral economics. Maximum incentive = $50/month if all appointments attended. Incentives will be pro-rated by percentage of appointments attended. Pro-rating strategies (e.g., uniform amount per appointment, escalating [aka, 'back-loaded'], or decreasing [aka 'frontloaded'] will be sequentially changed based on acceptability and other intervention-related data gathered from participants during the trial.

    Clinician-participants will not receive any intervention, but will receive surveys and interviews to assess their perceptions about the optimization, acceptability, scalability, and other implementation barriers/facilitators for the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of intervention measure (AIM)

    The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.

    Measured: Change at 8 months

  2. Acceptability of intervention measure (AIM)

    The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.

    Measured: Change at 6 months

  3. Acceptability of intervention measure (AIM)

    The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.

    Measured: Change at 4 months

  4. Feasibility of intervention measure (FIM)

    The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

    Measured: Change at 8 months

  5. Feasibility of intervention measure (FIM)

    The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

    Measured: Change at 6 months

  6. Feasibility of intervention measure (FIM)

    The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.

    Measured: Change at 4 months

Secondary outcomes (9)

  1. Implementation Survey Response

    Implementation survey. Results will be used to optimize intervention from implementation perspective.

    Measured: Change at 8 months

  2. Implementation Survey Response

    Implementation survey. Results will be used to optimize intervention from implementation perspective.

    Measured: Change at 6 months

  3. Implementation Survey Response

    Implementation survey. Results will be used to optimize intervention from implementation perspective.

    Measured: Change at 4 months

  4. Motivation Survey Response

    Motivation survey. Results will be used to optimize intervention from motivation perspective.

    Measured: Change at 8 months

  5. Motivation Survey Response

    Motivation survey. Results will be used to optimize intervention from motivation perspective.

    Measured: Change at 6 months

  6. Motivation Survey Response

    Motivation survey. Results will be used to optimize intervention from motivation perspective.

    Measured: Change at 4 months

  7. Ethical Concern Survey Response

    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.

    Measured: Change at 8 months

  8. Ethical Concern Survey Response

    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.

    Measured: Change at 6 months

  9. Ethical Concern Survey Response

    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.

    Measured: Change at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Feb 2025
  3. Primary completion18 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05967195
Sponsor's protocol ID
2023-03
Status last verified
Oct 2026
First submitted
20 Jun 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Financial Incentive and Text-Messages in people with First-Episode Psychosis, run by University of Pennsylvania at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of intervention measure (AIM) (time frame: Change at 8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05967195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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